[Federal Register Volume 68, Number 244 (Friday, December 19, 2003)]
[Notices]
[Pages 70826-70827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31326]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Zenapax (Humanized 
Antibody Against the IL-2 Receptor Alpha Chain) as a Novel Treatment 
for Multiple Sclerosis

AGENCY: National Institutes of Health, Public Health Services, DHHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive license to practice the inventions embodied in U.S. 
provisional patent application 60/393,021 (DHHS ref. no. E-143-2002/0-
US-01) filed June 28, 2002, international PCT application PCT/US02/
38290 (DHHS ref. no. E-143-2002/0-PCT-02), international PCT 
application PCT/US03/20428 (DHHS ref. no. E-143-2002/0-PCT-04), and 
United States Patent Application Serial No. 10/607,598 (DHHS ref. no. 
E-143-2002/0-US-03), all entitled, ``Zenapax (Humanized Antibody 
Against the IL-2 Receptor Alpha Chain) As A Novel Treatment for 
Multiple Sclerosis,'' and all corresponding foreign patent applications 
to Protein Design Laboratories, of Fremont, California. The patent 
rights in these inventions have been assigned to the United States of 
America.
    The prospective exclusive license territory will be worldwide. The 
field of use may be limited to the treatment of multiple sclerosis 
using monoclonal antibodies against the interleukin-2 receptor.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before February 17, 
2004 will be considered.

ADDRESSES: Requests for copies of the patent(s)/patent application(s), 
inquiries, comments and other materials relating to the contemplated 
exclusive license should be directed to: Catherine M. Joyce, 
Intellectual Property Management Specialist, Office of Technology 
Transfer, National Institutes

[[Page 70827]]

of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: 301-435-5031; Facsimile 301-402-0220; email 
[email protected].
    Technology Brief: The above-referenced patent(s)/patent 
application(s) relate to the discovery that a humanized antibody to the 
interleukin-2 receptor alpha chain (IL-2R[alpha]) (humanized anti-Tac 
antibody), dacluzimab, is effective in treating multiple sclerosis 
(MS). In particular, it has been discovered that patients who failed to 
respond to therapy with interferon-beta showed dramatic improvement 
when treated with dacluzimab, with patients showing both a reduction in 
the total number of lesions and cessation of appearance of new lesions 
during the treatment period.

SUPPLEMENTARY INFORMATION: The prospective exclusive license will be 
royalty-bearing and will comply with the terms and conditions of 35 
U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be 
granted unless within sixty (60) days from the date of this published 
notice, the NIH receives written evidence and argument that establish 
that the grant of the license would not be consistent with the 
requirements of 35 U.S.C. 209 and 37 CFR 404.7
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted to 
this notice will not be made available for public inspection and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: December 10, 2003.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 03-31326 Filed 12-18-03; 8:45 am]
BILLING CODE 4140-01-P